CancerNCT04626830
Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management
A study testing Mobile Application Intervention in people with Cancer and Adherence to Medication Regime, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Adherence to Medication Regime, Symptom Management
- What is being tested?
- Mobile Application Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Using OAAs for cancer treatment and taking at least one cure
- Taking OAAs for at least six months
- Knowing the diagnosis
- Communicating verbally
- Scoring less than three on the Eastern Cooperative Oncology Group (ECOG) scale
- Having a smartphone with IOS or Android software
Show all 9Show fewer
- Actively using the smartphone
- Consenting to download the mobile application on one's mobile phone
- Volunteering to participate in the research.
Who cannot join
- Participation in a similar study aimed at increasing treatment adherence
- Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
- Having a smartphone with Windows or Blackberry software.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Mobile Application on Treatment Adherence and Symptom Management in Patients Using Oral Anticancer Agents: A Randomized Controlled Trial
The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application can help improve the cancer treatment process in people who are used oral anticancer agents. This study will be done a randomized-controlled trial to test the intervention.
Read the detailed description
Background: The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.
Objective/Hipothesis: The purpose of this study is to explore the effectiveness of a mobile application on treatment adherence and symptom management in patients using OAA. The following hypotheses (H) will teste in this study:
H0a: A mobile application developed for patients using OAA has not increased treatment adherence.
H1a: A mobile application developed for patients using OAA has increased treatment adherence.
H0b: A mobile application developed for patients using OAA has not decreased the frequency and severity of symptoms.
H1b: A mobile application developed for patients using OAA has decreased the frequency and severity of symptoms.
Study Design: The investigators will recruit and randomly assign 100 patients from the two cancer care sites who have recently been prescribed oral anticancer agents to receive either the mobile app intervention or standard care. Participants will be stratified by age and anticancer treatment ( i.e. simple and complex) regimen. Patients will be follow 6 months. Medication adherence, symptom severity will serve as primary outcomes.
- Conditions
- Cancer, Adherence to Medication Regime, Symptom Management
- Being tested
- Mobile Application Intervention
- Keywords
- Cancer, Mobile applications, Oral anticancer agents, Oral Chemotherapy, Medication adherence, Nursing
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application InterventionOther
Participants appointed to the intervention group will receive the mobile application intervention for six months after enrollment. The mobile app (OKTED) intervention will consist of completing responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Intervention | Experimental | Participants in the intervention group will receive 6 months the mobile application (OKTED) for improving symptoms and adherence to oral anticancer agents. The mobile application will consist of three modules. The first module will include OAA-specific information, a calendar in which start/end dates can be record, and a medication reminder. The second module will include information about common and urgent symptoms and recommendations for the management of these symptoms. The last module will comprise a question and answer section. Receives: Other: Mobile Application Intervention |
| Standard Care | No intervention | Participants in the control group will receive standard oncology care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence to Oral Anticancer Agents
The patients' adherence levels will be assess using the Oral Chemotherapy Adherence Scale (OCAS). The OCAS was developed by Bagcivan and Akbayrak (2015), and its Cronbach α coefficient was found to be 0.738. The scale (19 items, 5-point Likert-type) is a valid and reliable scale for adult patients who use OAAs. A total score of 84 and above is interpreted as "good adherence;" a total score of 83 and below is interpreted as "poor adherence".
Measured: baseline, 1 month, 3 months, 6 months
Change in Symptoms and Side Effects
The Memorial Symptom Assessment Scale (MSAS) is a multidimensional tool developed to evaluate the prevalence, characteristics, and distress levels of common cancer-related symptoms over seven days (Cronbach α=0.84). The MSAS is a reliable and valid instrument in the Turkish population. The scale has 32 items and three sub-dimensions: The Global Distress Index, The Physical Symptom Distress Scores, and The Psychologic Symptom Distress Scores. The total MSAS score is the average of the symptom scores of all 32 items. Twenty-four symptoms are evaluated in terms of severity, frequency and distress, and eight symptoms are evaluated in terms of severity and distress. If a symptom was experienced, the patient describes its severity on a 4-point categorical scale; its frequency, if appropriate, on a 4-point categorical scale; and its associated distress on a 5-point categorical scale. Each symptom score is the average of the dimensions (frequency, severity, distress dimensions).
Measured: baseline, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start25 Jun 2018
- Primary completion31 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University, Gazi University
- Responsible party
- Principal investigator, Akile Karaaslan Eşer, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626830
- Sponsor's protocol ID
- Project No: 2018.1.18.
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karaaslan-Eser A, Ayaz-Alkaya S. The effect of a mobile application on treatment adherence and symptom management in patients using oral anticancer agents: A randomized controlled trial. Eur J Oncol Nurs. 2021 Jun;52:101969. doi: 10.1016/j.ejon.2021.101969. Epub 2021 May 4.
PubMed 33991868
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mobile Application on Treatment Adherence and Symptom Management in Patients Using Oral Anticancer Agents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04626830
- Acronym / sponsor ID
- Project No: 2018.1.18.
- Conditions
- Cancer, Adherence to Medication Regime, Symptom Management
- Keywords
- Cancer, Mobile applications, Oral anticancer agents, Oral Chemotherapy, Medication adherence, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Koç University, Gazi University
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application can help improve the cancer treatment process in people who are used oral anticancer agents. This study will be done a randomized-controlled trial to test the intervention.
Detailed description
Background: The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.
Objective/Hipothesis: The purpose of this study is to explore the effectiveness of a mobile application on treatment adherence and symptom management in patients using OAA. The following hypotheses (H) will teste in this study:
H0a: A mobile application developed for patients using OAA has not increased treatment adherence.
H1a: A mobile application developed for patients using OAA has increased treatment adherence.
H0b: A mobile application developed for patients using OAA has not decreased the frequency and severity of symptoms.
H1b: A mobile application developed for patients using OAA has decreased the frequency and severity of symptoms.
Study Design: The investigators will recruit and randomly assign 100 patients from the two cancer care sites who have recently been prescribed oral anticancer agents to receive either the mobile app intervention or standard care. Participants will be stratified by age and anticancer treatment ( i.e. simple and complex) regimen. Patients will be follow 6 months. Medication adherence, symptom severity will serve as primary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Intervention | Experimental | Other: Mobile Application InterventionParticipants in the intervention group will receive 6 months the mobile application (OKTED) for improving symptoms and adherence to oral anticancer agents. The mobile application will consist of three modules. The first module will include OAA-specific information, a calendar in which start/end dates can be record, and a medication reminder. The second module will include information about common and urgent symptoms and recommendations for the management of these symptoms. The last module will comprise a question and answer section. |
| Standard Care | No intervention | –Participants in the control group will receive standard oncology care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Using OAAs for cancer treatment and taking at least one cure
- Taking OAAs for at least six months
- Knowing the diagnosis
- Communicating verbally
- Scoring less than three on the Eastern Cooperative Oncology Group (ECOG) scale
Key exclusion criteria (3 listed)
- Participation in a similar study aimed at increasing treatment adherence
- Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
- Having a smartphone with Windows or Blackberry software.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application InterventionParticipants appointed to the intervention group will receive the mobile application intervention for six months after enrollment. The mobile app (OKTED) intervention will consist of completing responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. | Other | Mobile Application Intervention |
Primary outcome
Change in Adherence to Oral Anticancer Agents
Time frame: baseline, 1 month, 3 months, 6 months
The patients' adherence levels will be assess using the Oral Chemotherapy Adherence Scale (OCAS). The OCAS was developed by Bagcivan and Akbayrak (2015), and its Cronbach α coefficient was found to be 0.738. The scale (19 items, 5-point Likert-type) is a valid and reliable scale for adult patients who use OAAs. A total score of 84 and above is interpreted as "good adherence;" a total score of 83 and below is interpreted as "poor adherence".
Change in Symptoms and Side Effects
Time frame: baseline, 1 month, 3 months, 6 months
The Memorial Symptom Assessment Scale (MSAS) is a multidimensional tool developed to evaluate the prevalence, characteristics, and distress levels of common cancer-related symptoms over seven days (Cronbach α=0.84). The MSAS is a reliable and valid instrument in the Turkish population. The scale has 32 items and three sub-dimensions: The Global Distress Index, The Physical Symptom Distress Scores, and The Psychologic Symptom Distress Scores. The total MSAS score is the average of the symptom scores of all 32 items. Twenty-four symptoms are evaluated in terms of severity, frequency and distress, and eight symptoms are evaluated in terms of severity and distress. If a symptom was experienced, the patient describes its severity on a 4-point categorical scale; its frequency, if appropriate, on a 4-point categorical scale; and its associated distress on a 5-point categorical scale. Each symptom score is the average of the dimensions (frequency, severity, distress dimensions).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 33991868Karaaslan-Eser A, Ayaz-Alkaya S. The effect of a mobile application on treatment adherence and symptom management in patients using oral anticancer agents: A randomized controlled trial. Eur J Oncol Nurs. 2021 Jun;52:101969. doi: 10.1016/j.ejon.2021.101969. Epub 2021 May 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application Intervention in people with Cancer and Adherence to Medication Regime, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adherence to Oral Anticancer Agents (time frame: baseline, 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.